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Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Information source: Centro per le Malattie Tropicali
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Strongyloidiasis

Intervention: Ivermectin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centro per le Malattie Tropicali

Overall contact:
Dora Buonfrate, MD, Phone: +39 601 3563, Email: dora.buonfrate@sacrocuore.it


Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. Aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.

Clinical Details

Official title: Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: clearance of strongyloides infection

Secondary outcome:

All-cause mortality during the 12 months of follow-up.

Patients with partial response to treatment at T 2

Patients with adverse reactions

Patients with increase in blood ALT over cutoff value

Patients with decrease in WBC count below cutoff value

Average difference in blood ALT and WBC count at day 17, compared with baseline

Average difference in blood eosinophil count at T2, compared with baseline


Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Male and female patients older than 5 years and weighting > 15 kg

- Current residence in non-endemic areas

- Either direct diagnosis of S. stercoralis infection AND positive serology at any

titer OR positive serology at "high" titer, irrespective of results of direct tests Exclusion Criteria:

- Pregnant or lactating women

- Subjects suffering from CNS diseases

- Disseminated strongyloidiasis

- Immunocompromised patients.

- Lack of informed consent

- Previous treatment with ivermectin (in the last year)

Locations and Contacts

Dora Buonfrate, MD, Phone: +39 601 3563, Email: dora.buonfrate@sacrocuore.it

IMTA, Antwerp, Belgium; Not yet recruiting

Clinica di Malattie Infettive e Tropicali, Brescia, Italy; Recruiting

UFDID, Azienda Ospedaliero-universitaria Careggi, Florence, Italy; Recruiting

Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital, Florence, Italy; Active, not recruiting

Reparto Malattie Infettive, Ospedale Ca' Foncello, Treviso, Italy; Active, not recruiting

UPCH, Hospital Cayetano Heredia, Lima, Peru; Not yet recruiting

FCRB, Hospital Clinic de Barcelona, Barcelona, Spain; Active, not recruiting

Unitat Medicina Tropical i Salut Internacional Drassanes, Barcelona, Spain; Not yet recruiting

UCLH, London, United Kingdom; Active, not recruiting

Unidad de Medicina, Hospital de Poniente-El Ejido, El Ejido, Almeria, Spain; Recruiting
Joaquin Salas Coronas, Principal Investigator

Centro per le Malattie Tropicali, Ospedale Sacro Cuore, Negrar, Verona 37024, Italy; Recruiting

Additional Information

Starting date: March 2013
Last updated: January 20, 2014

Page last updated: August 23, 2015

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